Apremilast Safety and PK Study in Recalcitrant Plaque Psoriasis

Conditions

• Plaque-Type Psoriasis
• Psoriasis-Type Psoriasis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Apremilast — DRUG
  20 mg PO (by mouth) twice per day (BID) for 84 days and then an additional 84 days during the optional treatment extension period. For subjects meeting the dose escalation criteria, dosage during the optional treatment extension period can be increased to 30 mg BID.

Study Details

The study will test the safety and tolerability of Apremilast twice a day in participants with recalcitrant plaque type psoriasis.

Key Dates

First listed

Aug 27, 2007

Start date

Aug 1, 2007

Status verified

Apr 2020

Primary completion

Apr 1, 2009

Completion

May 1, 2009

Study Design

Enrollment

31 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Apremilast 20 mg BID/ 30 mg BID
  Apremilast 20 mg or 30 mg orally twice per day

Primary Outcome Measure

Treatment Emergent Adverse Events (TEAEs) During the Treatment Phase [ Time Frame: Week 0 to Week 12 ]

Locations (4)

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